BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S081 · Decision Sep 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55

    Basic Information

    Device Name
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
    Trade Name
    GENESIS IPG, EON IPG, EON C IPG, EON MINI IPG, PROTEGE IPG
    PMA Number
    P010032
    Supplement Number
    S081
    Device Class
    FDA Class 3
    Product Code
    LGW
    Generic Name
    Stimulator, spinal-cord, totally implanted for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 16, 2014
    Date Received
    June 11, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MATERIAL CHANGE TO THE PORT PLUG USED IN THE APPROVED IMPLANTED PULSE GENERATORS (IPG MODELS 3608, 3688, 3716, 3788 AND 3789). THE PORT PLUG IS AN ACCESSORY TO THE IPG USED TO BLOCK TISSUE INGRESS INTO THE IPG HEADER. WHEN IMPLANTING ONLY A SINGLE LEAD IN AN IPG CONTAINING DUAL LEAD PORTS, THE PORT PLUG IS INSERTED INTO THE UNUSED LEAD PORT AND SECURED BY TIGHTENING THE SETSCREW ONTO THE PORT PLUG.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief